Method and apparatus for follicular extraction and transplantation

ABSTRACT

Apparatus and method are for extraction of follicular units. A dermal biopsy punch is utilized in combination with a suction device for extraction purposes. The use of suction to extract the follicular unit allows for distribution of the forces over a large area of the unit, helping to keep the unit intact. A perforating device, affixed to the punch, is utilized to weaken the structural integrity of the extraction area. The perforating device, having a plurality of spike members which surround the follicular unit and are inserted into the skin at a small, previously determined depth, reduces the holding tissue around the unit. The small number of relatively thin spikes of the perforating device help keep the follicular unit undamaged. Because suction is utilized to extract the follicular unit, the distal end of the apparatus may have a guard which functions to prevent the extracted follicular units from being vacuumed further therein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is an improved method and apparatus for extractionof follicular units from a donor area, for the purpose oftransplantation into balding areas of the scalp.

2. Description of the Prior Art

Numerous innovations for hair transplant procedures have been providedin the prior art that are described as follows. Even though theseinnovations may be suitable for the specific individual purposes towhich they address, they differ from the present invention ashereinafter contrasted. The following is a summary of those prior artpatents most relevant to the invention at hand, as well a descriptionoutlining the differences between the features of the present inventionand those of the prior art.

1. U.S. Pat. No. 5,989,279, invented by Rassman, entitled “HairImplantation Device”

The patent to Rassman describes a system for transplanting hair graftsfrom a donor region of a patient's scalp to a recipient region of thepatient's scalp. The system includes harvesting N (N>21) strips of skincontaining living hair follicles from the donor region of the patient'sscalp, the N strips of skin being harvested simultaneously, and cuttingthe N strips of skin into hair grafts, the N strips of skin being cutsimultaneously. The system also includes loading the hair graftssequentially, bottom down, into a removable cartridge connected to aninstrument for implanting the hair grafts into the recipient region ofthe patient's scalp, the hair grafts being loaded so as to create an airseal between the hair grafts and the cartridge, and implanting the hairgrafts. The implanting includes implanting the hair grafts into therecipient region of the patient's scalp, one at a time, using theinstrument, by feeding a hair graft to a predetermined feed position inthe instrument via air suction created by an air seal between the hairgraft and the cartridge, making an incision at a point in the recipientregion of the patient's scalp at which the hair graft is to be implantedusing a cutting device on the instrument, and sliding the hair graftinto the incision using an implanting member in the instrument.

Other relevant prior patents to Rassman include U.S. Pat. No. 5,782,851,entitled “Hair Transplantation System,” U.S. Pat. No. 5,817,120,entitled “Hair Implanting Instrument,” and U.S. Pat. No. 5,584,841,entitled “Instrument For Implanting Hair Grafts”.

2. U.S. Pat. No. 5,989,273, invented by Arnold, entitled “Apparatus ForProducing Hair Transplantation Donor Strips And Methods”

The Arnold invention provides methods and apparatus for producing hairtransplantation donor strips for use in hair transplantation procedures.According to one exemplary method, a surgical instrument is providedhaving at least two planar blades, with each blade having a sharpenededge, and with the blades being substantially parallel to each other.The blades are translated along and through an area of the scalp havinghair to form at least two parallel incisions in the scalp. Theorientation of the blades relative to the hair is adjusted such that theblades are generally aligned at all times with the direction of hairgrowth for the hair between the blades when the surgeon is making theincisions. A graft of skin having hair is then removed from between theincisions formed by the blades. At least a portion of the graft of skinhaving at least one hair is then placed into another area of the scalp.

3. U.S. Pat. No. 6,027,512, invented by Bridges, entitled “Hair FollicleHarvesting Device”

The patent to Bridges describes a hair follicle harvesting device whichis characterized by a pencil-like harvesting tube fitted at the distalend with a needle of selected bore size for insertion over one or morehairs and hair follicles in a scalp flap and puncturing the scalp flap.The harvesting tube is connected at the proximal end to a source ofsaline solution and accommodates a flow of saline solution through aventuri or tube constriction by operation of a pump to remove theencircled and loosened hair follicles as micrografts, minigrafts andhair plugs from the scalp flap. The hair follicles are caused to flowthrough the needle and into the saline solution stream by reducedpressure responsive to flow of the saline solution through the venturior tube constriction located near the base of the needle in theharvesting tube. The saline stream containing the hair follicles is thendirected from the harvesting tube through a screen in a disposablefollicle harvesting apparatus or a screen in a follicle collectionvessel, which retains the hair follicles on the screen and returns thesaline solution to the pump for continued circulation through theharvesting tube. The screen is periodically removed from the harvestingapparatus or follicle collection vessel to collect the harvested hairfollicles, which are then used in conventional hair transplantprocedures.

4. U.S. Pat. No. 5,611,811, invented by Goldberg, entitled “Micro AndMini Hair Transplant Device”

The patent to Goldberg describes a device for automating hair transplantprocedures. The device includes a part for puncturing the scalp, a partfor containing the hair grafts to be transplanted, a part for ejectingthe hair grafts from the containing means, a part for actutating theejecting means and a part for delivering the hair grafts into thetransplant site.

5. U.S. Pat. No. 5,827,297, invented by Boudjema, entitled “Device ForTransplanting Small Diameter Hair Grafts”

The patent to Boudjema describes a device for transplanting smalldiameter hair grafts using a hand-held cutting instrument having a bodyholding the tool, a rotary cylindrical tool and a drive assembly capableof driving the tool in rotation with respect to the body. The tool has ahollow end for cutting a graft. The cylindrical tool is a hollow needlewith an axial through bore of the same diameter as the hollow cuttingend to which it forms an extension. The device extracts the graft bysucking it up through the axial bore of the needle.

6. U.S. Pat. No. 5,693,064, invented by Arnold, entitled “Dermal PunchFor Hair Transplantation And Methods”

In one aspect, the Arnold invention provides a method for transplantinghair. According to the method, an instrument is provided having aconcentric cylindrical shaft having a proximal end, a distal end, and anaxis extending therebetween A blade is on the distal end of the shaftnormal to the axis of the shaft, and an escape port is provided in thewall of the shaft near the distal end. The instrument is inserted intothe skin to a preselected depth where the skin is below the escape portto form a cylindrical incision. The instrument is then removed from theskin. The step of inserting the instrument into the skin is repeated,with any accumulated skin in the shaft being forced through the escapeport. In this way, the shaft does not become clogged with tissue afterrepeated use. A graft of skin having at least one hair is then placedinto at least one of the cylindrical incisions.

7. U.S. Pat. No. 6,059,807, invented by Boudjema, entitled “Device ForImplanting Small-Diameter Capillary Grafts”

The patent to Boudjema describes a device for implanting asmall-diameter capillary graft into the scalp, comprising a hollowneedle pierced by a throughbore having a smaller diameter than the graftand suitable for gripping, by its end, one end of the said graft throughthe needle. The needle is mounted so as to slide in a cylindrical sheathbetween a first position, in which the needle is retracted inside thesheath, and a second position for gripping and for inserting the graftinto the scalp, in which the needle projects beyond the end of thesheath. The needle is actuated between the first and second positions,preferably by application and release of a vacuum to an enclosure whichis defined by a cylindrical tube and which is closed on a first side bythe sheath and on a second side by a plug fastened to a distal end ofthe needle. A communication port is formed in the needle communicatingwith the enclosure, so as to allow vacuum in the enclosure to facilitategripping of the capillary graft by vacuum, and an orifice is provided ina wall of the cylindrical tube so as to allow a surgeon rapidly to applyand release vacuum in the enclosure.

8. U.S. Pat. No. 5,417,683, invented by Shiao, entitled “Mini-Graft HairImplanting Device For Implanting Multiple Clumps Of Hair Follicles AtOne Time”

The patent to Shiao describes a mini-graft hair implanting device forimplanting multiple clumps of hair follicles at one time includes abarrel, a plunger and a depth control unit. The barrel is formed as ahollow cylinder with an open top and a bottom wall that has a cluster ofhollow needles which are attached thereto so as to extend downwardlytherefrom. Each of the hollow needles is adapted to receive a clump ofhair follicles therein and has two open ends, a distal one of which istapered so as to form a pointed tip. The plunger extends slidably intothe barrel and has a bottom end that is formed with a set of downwardlyextending first push rods and at least one downwardly extending secondpush rod. The first push rods are aligned with and extend into thehollow needles. The depth control unit is attached to and extendsdownwardly from the bottom wall of the barrel. The depth control unitincludes at least one tube which is shorter than the hollow needles andwhich has two open ends, a distal one of which is blunt. Each secondpush rod is aligned with and extends into a corresponding tube.

9. U.S. Pat. No. 6,461,369, invented by Kim, entitled “HairTransplanter”

The Kim invention discloses a hair transplanter. A needle to be insertedinto a scalp has a pointed end portion to reduce damage of the scalp,and a guide plate in adhered to an end portion of a sliding unitreciprocating in the longitudinal direction of the needle outside theneedle, in order to prevent hair roots from being separated at the timeof the separation of the needle. As a result, the hair roots insertedinto a needle insertion groove are not damaged and are naturally settledin the scalp without modification, thereby stably performing the hairtransplantation.

10. U.S. Pat. No. 5,951,572, invented by Markman, entitled “Method,Apparatus And Kit For Performing Hair Grafts”

In the patent to Markman, a device and method are set forth forperforming hair grafts which includes a housing, plunger with a needle,and a carriage containing an inventory of hair grafts to be placed. Theplunger is placed at an extended position where the needle extends fromthe catheter and the needle and catheter are inserted into the tissue.The plunger and needle are withdrawn and the carriage is indexed toposition a graft. The plunger is moved to urge the graft from thecarriage through the catheter into the tissue for transplantation.

The above-listed prior art largely relates to methods known in the art,such as the “strip method” (first-above-listed patent to Rassman, secondabove-listed patent to Arnold) as well as cylindrical cutting tools forextraction, and various hollow needles used in the extraction process.In addition, various prior art relates to the implantation of follicularunits, as distinguished from device designed to facilitate extraction.

In contrast to all of the above, the present invention provides twoinnovations to improve follicular unit extraction. The first utilizes adermal biopsy punch and suction device which allows for distribution offorces over a greater area of the follicular unit to mitigate crushforce upon the unit, and keep the same intact.

The second innovation utilizes a perforator with a plurality of thinspikes inserted into the skin to surround the follicular unit and weakenthe structural integrity of the area. Because the follicular unit isbeing partially sucked into the punch, the holding tissue is decreased,allowing the follicular unit to become free. This prevents damage to thefollicular units safely extracts high quantities of follicular units ina short period of time, while maintaining the integrity of suchfollicular units.

SUMMARY OF THE INVENTION

As noted, the present invention is an improved method and apparatus forextraction of follicular units from a donor area, for the purpose oftransplantation into balding areas of the scalp.

Recent methods of extraction include the usage of a 1 mm dermal biopsypunch (placed over the follicular unit and pushed through the skin) incombination with a fine forceps (for subsequent “plucking” of thefollicular unit). Such often leads to portions of the follicular unitbeing shaved off by the punch, injuring or killing the unit. Attempts tosolve this problem include the sliding of the punch only part way down,and pulling the partially freed follicular unit with fine forceps untilthe remaining supporting dermis gives way. This, however, leads tocrushing or tearing of the follicular unit, as well as lengthy delaysbetween each extraction.

The present method and apparatus seek to circumvent the above-describedproblems. The first method utilizes the previously-existing dermalbiopsy punch in combination with a suction device for extractionpurposes. The suction allows for distribution of forces over a greaterarea of the follicular unit than previously attained. This mitigates the“crush force” upon the follicular unit, thus helping keep the unitintact. Moreover, because this method does not require repeatedlyputting down the punch and picking up the forceps, the extractionprocess is sped up significantly.

The second innovation utilizes a perforating device that is designed toweaken the structural integrity of the area in question, which greatlyfacilitates extraction of the follicular unit. The perforation devicecomprises a plurality of “spike” members which surround the follicularunit and are inserted into the skin at a small, previously-determineddepth. Because this takes place while the follicular unit is beingpartially sucked into the punch, the holding tissue is decreased,allowing the follicular unit to become free. Because the device utilizessuction as a means of extraction rather than collection of follicularunits, the distal end of the device comprises a guard which functions toprevent the extracted follicular units from being vacuumed furthertherein.

Importantly, because the spikes are relatively thin, and because only asmall quantity of spikes are needed, the device is unlikely to damagethe follicular units. In addition, because the perforator weakens thesurrounding tissue, the device allows patients with strong dermalconnective tissue to be candidates for the procedure. In total, thepresent invention provides a safe means to extract significantquantities of follicular units in a relatively short period of time,while maintaining the integrity of such follicular units.

In light of the foregoing, it is generally an object of the presentinvention to provide an effective means to extract follicular units froma donor area and transplant same into balding areas of the scalp

It is also an object of the invention to provide an extraction meansthat maintains the integrity of the follicular unit.

It is a specific object of the present invention to provide an effectiveextraction means that does not rely upon the usage of forceps, whichoften crush or tear the follicular unit.

It is also an object of the invention to utilize a perforating devicewith a plurality of spike members, designed to weaken the structuralintegrity of the area in question, greatly facilitating extraction ofthe follicular unit,

It is another object of the present invention to provide the perforatorwith a small quantity of relatively thin spikes, which are unlikely todamage the follicular units in question.

It is a further object of the invention to uniquely utilize suction as ameans of extraction, as distinguished from a means of collection offollicular units.

It is a further object of the present invention to provide a device witha follicular unit guard which functions to prevent extracted follicularunits from being vacuumed further within the device.

It is also an object of the present invention to allow patients withstrong dermal connective tissue to be candidates for the extraction andplacement procedure.

It is an additional object of the invention to provide an extractionmeans that is significantly faster than those of the prior art,increasing the efficiency of the procedure and decreasing the cost ofthe procedure for the patient.

Finally, it is also an object of the present invention to provide a safemeans to extract significant quantities of follicular units in arelatively short period of time.

The novel features which are considered characteristic for the inventionare set forth in the claims. The invention itself, both as to itsconstruction and its method of operation, together with additionalobjects and advantages thereof, will be best understood from thefollowing description of the embodiments when read and understood inconnection with accompanying drawings.

BRIEF DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 depicts a prior art method and apparatus, for the purposes ofdiscussion, illustrating a previously-existing punch approaching afollicular unit.

FIG. 2 depicts a prior art method and apparatus, for the purposes ofdiscussion, illustrating a follicular unit broken off through usage ofthe previously-existing punch mechanism.

FIG. 3 is a perspective view of the present invention, including punchdevice, perforating mechanism thereon, handle, and components of suctionmeans.

FIG. 4 is a three-quarter cut-away view of the present invention,illustrating the punch device, perforator, and follicular unit guardmechanism.

FIG. 5 is a side view of the present invention, illustrating theperforator in extended position above a follicular unit, and showing anoutline of an incision created by the punch with perforator.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

As noted herein, recent methods of extraction include the usage of a 1mm dermal biopsy punch placed over the follicular unit and pushedthrough the skin. Such is in combination with a fine forceps, used forsubsequent “plucking” of the follicular unit. However, this procedureoften leads to portions of the follicular unit being shaved off by thepunch, with the remainder of the follicular unit attached to connectivetissue. Thus, the fine forceps of the known procedure result in theinjuring or killing the entire follicular unit, in turn defeating thepurpose of extraction for transplantation.

Attempts to solve this problem include the sliding of the punch onlypart way down, and pulling the partially freed follicular unit with fineforceps until the remaining supporting dermis gives way. This, however,often leads to crushing or tearing of the follicular unit, as well aslengthy delays between each extraction.

To illustrate the typical problem of currently used procedures, FIG. 1is a view of prior art, shown for the purpose of discussion, showing apreviously-existing punch (16) approaching a follicular unit (26), alarge portion of which is below the skin line (28) and within the scalparea (30). In addition, FIG. 2 is a subsequent view of a common priorart method, illustrating the follicular unit (26) broken off throughusage of the prior method.

It should also be noted that because follicular units are not alwaysparallel to the punch along the vertical axis, additional tearing andbreaking problems often occur. For the purposes of example, if theportion of the follicular unit below the skin line in FIG. 1 were to berotated to a degree approaching perpendicular to the skin line, thebiopsy punch, when be pushed downwardly, would shear the follicularunit, injuring or killing the same.

Thus, based on the foregoing, a significant need exists for an apparatusand method for follicular unit extraction that dispenses with the needfor fine forceps, and which is less likely to cause follicular unitdamage than the standard biopsy punch.

The present invention, through usage of items such as suction and aperforator, accomplishes the above objectives. FIG. 3 is a perspectiveview of a preferred mode of the present invention, including its punchdevice, perforating mechanism, handle, and suction means components.

Specifically, the apparatus for follicular extraction (10) comprises agenerally elongated handle (12) to be engaged by the user. The handle(12) comprises a tapering portion (14) at the front or distal end. Asmall, generally cylindrical biopsy punch (16) is removably attached tothe tapering portion of the handle (14). As noted, the punch may be astandard 1 mm biopsy punch to accomplish the purposes of the invention.

A perforator (18) is affixed to the punch (16). The perforator comprisesan annular portion (18A), with an open end to allow the same to fitaround the punch (16). The perforator further comprises apreviously-determined quantity of spike members (18B), which extendalong the vertical axis of the punch, generally parallel thereto. Theperforator also comprises an extended member or handle portion (18C),which is of a shape that corresponds to and abuts the tapering portionof the handle (14) and lower portion of the handle itself (12). The endof the extended member (18C) extends outwardly from the handle to allowthe user to engage and same and slide the perforator down the punch,around which it is wrapped, to enter the scalp of the patient. Thisprovides a series of small apertures or “perforation” thereon.

The butt end of the handle (12) is inserted within a component of thesuction means (20), such as via a tube fitting that wraps around thehandle. It is to be understood that any appropriate suction meanscomponents, such as tubes, vacuum devices, and foot pedals that areknown in the art may be utilized in conjunction with the method andapparatus of the present invention. The departure of the presentinvention from the prior art lies in the effective usage of theperforator device (18), as well as through the usage of suction forextraction and not collection purposes.

To illustrate the above in greater detail, FIG. 4 is a three-quartercut-away view of the front end of the present invention, showing thepunch (16), perforator (18), and guard mechanisms (24). Of particularimportance is the guard member (24), which functions to containsuccessfully extracted follicular units. As noted, because the presentmethod utilizes suction to facilitate extraction, rather than as a meansof collection, the guard member (24) is needed to prevent the follicularunits from entering aperture (22) into the suction device.

Lastly, FIG. 5 is a side view of the present invention, illustrating theperforator (18) in extended position above a follicular unit (26). TheFIGURE also shows an outline of an incision created below the skin line(28) by the punch (16) with perforator (18), to a depth within the scalparea (30) that is similar to that of the follicular unit (26).

As shown, the spikes (18B) of the perforator (18) are gently pushedbelow the skin line (30), creating a plurality of small, spaced-apartapertures, or a perforation. Importantly, because the spikes (18B) arerelatively thin, the incidence of piercing or damaging the follicularunit (26) is greatly mitigated. It is to be understood that theparticular configuration of spikes shown is for the purposes of exampleonly, and that the center of the three spikes shown would fall before orbehind the follicular unit in a three-dimensional illustration, therebycausing no damage to same. Moreover, the spikes (18B) may be of avariety of diameter sizes consistent with these objectives, and varyingquantities of spikes may be utilized, depending upon particular need.

Because the perforator weakens the structural integrity of theconnective tissue, the follicular unit may be extracted considerablyeasier than through the usage of previous methods. As such, when suctionis applied to the area in question, the follicular unit gives way, andis stopped by the guard member. Importantly, this method of extractionkeeps the follicular unit intact for subsequent transplantation.Furthermore, the unique method of the present invention allows patientswith naturally string dermal tissue to become candidates for thetransplantation procedure, as the usage of perforation and suctiongreatly facilitate extraction and mitigate the incidence of damagedfollicular units.

Recent experimentation with the aforementioned method has yieldedpositive results, and it is believed that the method of the presentinvention may be conveniently adopted by all relevant medicalprofessionals. Because the components of the apparatus of the presentinvention are relatively inexpensive to manufacture, it is believed thatusage of the apparatus may be widespread in a relatively short period oftime. Finally, because one utilizing this method need not constantlyplace the punch down and pick up forceps, the present method isconsiderably faster than the methods of the prior art, much to thebenefit of both medical professionals and patients.

With regards to all descriptions and graphics, while the invention hasbeen illustrated and described as embodied, it is not intended to belimited to the details shown, since it will be understood that variousomissions, modifications, substitutions and changes in the forms anddetails of the device illustrated and in its operation can be made bythose skilled in the art without departing in any way from the spirit ofthe invention.

Without further analysis, the foregoing will so fully reveal the gist ofthe present invention that others can readily adapt it for variousapplications without omitting features that, from the standpoint ofprior art, constitute essential characteristics of the generic orspecific aspects of this invention. What is claimed as new and desiredto be protected by Letters Patent is set forth in the appended claims.

1. A method of extracting follicular units comprising the steps of:utilizing an apparatus with a generally elongated handle (12), whichcomprises a tapering portion (14) at an end thereof, partially insertinga generally cylindrical biopsy punch (16), which is removably attachedto the tapering portion of the handle (14), around a target follicularunit, inserting a perforator (18) around the target follicular unit, theperforator affixed to the punch (16), comprising an annular portion(18A), which comprises an open end to allow the same to fit around thepunch (16), the perforator further comprising a plurality of spikemembers (18B), which extend along the vertical axis of the punch,generally parallel thereto, the perforator also comprising an extendedmember (18C), which is of a shape corresponding to the tapering portionof the handle (14) and lower portion of the handle (12) and abuttingsame, the end of the extended member (18C) extending outwardly from thehandle to allow a user to engage the same and slide the perforator downthe punch, to engage a patient's scalp, providing a series of smallapertures resulting in a perforation thereon, and utilizing a suctionmeans affixed to a butt end of the handle (12), which functions tovacuum extracted follicular units towards a guard member (24), whichcontains follicular units and prevents same from entering an aperture(22) into the handle.
 2. The method as described in claim 1, utilizing a1 mm dermal biopsy punch.
 3. The method as described in claim 1,utilizing a perforator which comprises at least four spikes thereon. 4.The method as described in claim 1, wherein the punch is inserted toapproximately one half the depth of the follicular unit.
 5. The methodas described in claim 1, utilizing a handle constructed of a polymericmaterial.
 6. The method as described in claim 1, utilizing a punchconstructed of a metallic material.